MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TOTAL PSA

Catalog Number 07K70-25

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer reported a falsely decreased architect total psa on one patient.Results provided: (b)(6) 2020 = 4.306 / 2.841 / 4.864 / 4.786 / 4.569 ng/ml.No impact to patient management was reported.

Manufacturer Narrative

A review of complaints for the architect total psa, lot# 03330fn00 assay determined that there are no trends for the product related to patient results.Return testing was not completed as returns were not available.Global data was evaluated and the patient median result for lot 03330fn00 was analyzed and found to be within established baselines and confirms no systemic issues for this lot.A review of the manufacturing documentation did not identify any issues associated with the customers observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect total psa, lot# 03330fn00 assay.

• Brand Name: ARCHITECT TOTAL PSA
• Type of Device: TOTAL PSA
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9738997
• MDR Text Key: 221028919
• Report Number: 3008344661-2020-00018
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• PMA/PMN Number: P910007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2020
• Device Catalogue Number: 07K70-25
• Device Lot Number: 03330FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER LIST 01L86-01; ARCHITECT I1000SR ANALYZER LIST 01L86-01; SERIAL (B)(4) ; SERIAL (B)(4)